NCT05441995Unknown不适用
Cryotherapy Efficacy in 9 to17-year-old Children During Endodontic Treatment of the Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Parallel Controlled Trial
Minia University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of the study is to assess the efficacy of cryotherapy application on the success of inferior alveolar nerve block (IANB) in reducing pain during pulp therapy of the mandibular first permanent molars with irreversible pulpitis (IP) in children age from 7 to 16 years. The null hypothesis (H0) supposed no difference in pain intensity during pulp therapy of primary molars with IP anesthetized with IANB with and without cryotherapy application. The secondary aim was to evaluate the children's behavior before and after pulpectomy in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification.
- •Cooperative children (rate 3 or 4 according to Frankl behavior rating scale)
- •Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed.
- •No radiographic changes with at least two-thirds of the root must be evident.
排除标准
- •Children with severe emotional, intellectual, and behavioral difficulties.
- •Necrotic pulp of primary molars.
- •Unrestorable crowns
- •Positive history of gingival swelling, abnormal mobility, and fistulous tract.
- •Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.
结局指标
主要结局
Pain intensity
时间窗: up to 24 hours
Pain was assessed using Visual Analogue Scale (VAS)
次要结局
未报告次要终点
研究者
Ahmad Elheeny
Assistant Professor
Minia University
研究点 (2)
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